Setting the standard around the world
- Over 130,000 patients treated worldwide¹
- Pioneered the treatment with a PFO-specific device
Three extensive clinical studies confirm the superiority of PFO closure to medical management in reducing the risk of stroke recurrence.
|Devices used||100% Amplatzer™|
|39% Gore® Helex®|
61% Gore® Cardioform
|51% Amplatzer™ PFO Occluder;|
49% approved PFO devices
(median 5.9 yrs)
(median 3.2 yrs)
Not reported |
(median 5.4 yrs)
|Anticoaulant allowed |
in control group?
(Recurrent ischemic stroke
(Recurrent ischemic stoke)
(Recurrent ischemic stroke)
Freedom from > 9 bubbles
(Evaluated after 6 months)
Freedom from 25 bubbles
(Evaluated after 12 months)
Discover more about the largest trial with the most extensive patient follow-up of any trial conducted on PFO closure and its impact on the prevention of recurrent ischemic strokes.
*RCTs=Randomized Clinical Trials
**Patients in device group of each trial implanted with Amplatzer™ PFO occluder device: RESPECT = 465, PREMIUM = 119, PC = 191, CLOSE = 121, DEFENSE = 53, PRIMA = 41.
a. Saver JL, Carroll JD, Thaler DE, et al. Long-term outcomes of patent foramen ovale closure or medical therapy after stroke. N Engl J Med. 2017; 377: 1022-32.
b. Søndergaard L, Kasner SE, Rhodes JF, et al. Patent foramen ovale closure or antiplatelet therapy for cryptogenic stroke. N Engl J Med. 2017; 377: 1033-42.
c. Mas J-L, Derumeaux G, Guillon B, et al. Patent foramen ovale closure or anticoagulation vs. antiplatelets after stroke. N Engl J Med. 2017; 377: 1011-21.
d. This table focuses on PFO occluder group vs. antiplatelet only group.
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